Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Requirements on the chemical-pharmaceutical documentation for homeopathic and anthroposophic medicinal products of herbal origin - a critial evaluation
Ines Feile (Abschlußjahr: 2011)
Language: English
This master thesis mainly focuses on the currently requested quality requirements for homeopathic medicinal products and anthroposophic medicinal products (produced according to homeopathic principles) and discusses the challenges on how to meet these requirements in daily practice due to their particular specialities.
The quality aspect of medicinal products is independent from the product type or its authorisation procedure. Homeopathic and anthroposophic medicinal products as defined in Directive 2001/83/EC have to comply with all relevant legislation and guidelines as well as with relevant European Pharmacopoeia monographs or those in the Pharmacopoeia of a member state.
An overview of this existing and applicable regulatory frameworks and guidances is presented in this work. Special guidance on which information to include in a registration dossier for homeopathic and anthroposophic medicinal products is very limited. Manufacturers have to adapt the guidances given for chemically-defined and herbal medicinal products particularly. Their suitability for HAMPs is discussed and critical points are identified. Proposals for the harmonised content of the EU CTD Module 3 are made with respect to the special characteristics of this kind of products.
It is outlined why more specific and harmonised quality guidance for homeopathic and anthroposophic medicinal products with reasonable and pragmatical analytical requirements are needed.
Furthermore a short overview of practical examples of different quality requirements in some EU member states and Switzerland is presented.
Pages: 48
An overview of this existing and applicable regulatory frameworks and guidances is presented in this work. Special guidance on which information to include in a registration dossier for homeopathic and anthroposophic medicinal products is very limited. Manufacturers have to adapt the guidances given for chemically-defined and herbal medicinal products particularly. Their suitability for HAMPs is discussed and critical points are identified. Proposals for the harmonised content of the EU CTD Module 3 are made with respect to the special characteristics of this kind of products.
It is outlined why more specific and harmonised quality guidance for homeopathic and anthroposophic medicinal products with reasonable and pragmatical analytical requirements are needed.
Furthermore a short overview of practical examples of different quality requirements in some EU member states and Switzerland is presented.
Pages: 48